Events

Field Safety Notices about ARCHITECT Intact PTH Assay Reagents, Calibrators and Controls

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Abbott Laboratories.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2014(05)
  • Date
    2014-02-21
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/architect-intact-pth-assay-reagents-calibrators-and-controls&id=7978f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    Abbott has confirmed that a performance shift in the architect intact parathyroid (pth) assay has the potential to generate falsely elevated results on patient samples.  this issue affects architect intact pth assay list number 8k25, reagents (8k25-20, 8k25-25, 8k25-27*), calibrators (8k25-01) and controls (8k25-10). refer to attached field safety notice (fsn).  the scope of the issue affects devices manufactured between may 2012 and november 2013.  *note: this list number is not ce-marked and is distributed to usa and puerto rico only.
  • Action
    Abbott has launched a product recall for affected lots of ARCHITECT Intact PTH assay reagents, calibrators and controls and has issued a FSN to provide instructions on what actions your laboratory must take (as follows):  - Immediately discontinue use of, and destroy, any remaining inventory of ARCHITECT Intact PTH assay according to your laboratory procedures.  - To continue Intact PTH testing at your laboratory, Abbott recommends that you identify an alternate method for testing patient samples. If further guidance is needed, please contact your Abbott sales representative.  - This letter should be reviewed with the treating physician or healthcare provider to ensure they are aware of the issue and can determine whether re-evaluation of the patient is necessary.  - If you have forwarded any product to other laboratories, please inform them of this FSN.  The IMB recommends that results with the ARCHITECT Intact PTH assay are reviewed as appropriate to determine whether re-evaluation of the patient is necessary.  Please forward this safety notice to all those who need to be aware of this action within your organisation and to maintain awareness over this safety notice for an appropriate time period.

Device

ARCHITECT Intact PTH Assay Reagents, Calibrators and Controls
  • Model / Serial
  • Product Description
    ARCHITECT Intact PTH Assay Reagents, Calibrators and Controls
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HPRA